Combo Product Reforms May Appear in User Fees if Not Passed in Lame Duck

Combo Product Reforms May Appear in User Fees if Not Passed in Lame Duck

October 28, 2016, FDA Week

Wade Ackerman spoke at a DIA conference on October 24 and is quoted in an FDA Week article regarding combination product reform. 

According to Mr. Ackerman, there has been strong bipartisan support for 21st Century Cures and Medical Innovation bills. However, if combination product language does not get passed in this Congress, Ackerman also pointed to the FDA user fee agreements as a possible legislative vehicle next year.

"I think there's still really strong bipartisan support from at least what I hear, and from when I was there, to get something done this year in lame duck," Ackerman said. "As far as looking forward with these particular policies, I would just note that getting a new piece of legislation through the Senate HELP committee with bipartisan support is a significant accomplishment."  

Mr. Ackerman pointed to this momentum as a positive sign that these new policies on combination products would be enacted in some form, whether in lame duck this year or as part of the user fee reauthorization next year.

For additional information on the conference, please click here.